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Trial registered on ANZCTR


Registration number
ACTRN12614000708651
Ethics application status
Approved
Date submitted
18/06/2014
Date registered
4/07/2014
Date last updated
31/05/2019
Date data sharing statement initially provided
31/05/2019
Date results information initially provided
31/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of sleep posture on spinal symptoms
Scientific title
An observational study comparing the sleep posture of three groups (healthy, neck pain, lumbar pain) to determine the relationship between spinal symptoms and sleep posture measured using infrared imaging and questionnaires.
Secondary ID [1] 284831 0
none
Universal Trial Number (UTN)
U1111-1158-1763
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar pain 292216 0
Lumbar stiffness 292293 0
Lumbar bothersomeness 292294 0
Cervical pain 292295 0
Cervical stiffness 292296 0
Cervical bothersomeness 292297 0
Quality of sleep 292298 0
Condition category
Condition code
Musculoskeletal 292553 292553 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this observational study participants will be asked to complete the self-report questionnaires outlined below. They will be provided with an email link to access Survey Monkey questionnaires for online completion. If unable to access online, printed copies will be provided for manual completion.

Self Report Questionnaire;
1. Self-report percentage allocation sleep postures
2. General Questions; Age, Gender, Sleeping Arrangement: Partner/Solo, Height and Weight (BMI), Highest Education Level (High school, Registered Trade, Undergraduate, Post Graduate), Medications and Comorbidities.
3. 11 point numerical rating scales for bothersomeness, pain, stiffness and quality of sleep.

Medical Outcomes Study 36-Item Short-Form Health Survey
Spine Functional Index (SFI-10)
Neck Disability Index
Rowland Morris Disability Questionnaire
Hospital Anxiety and Depression Scale
Insomnia Severity Index
Pittsburgh Sleep Quality Index

Infrared cameras will be temporarily installed on stands, in the participant's bedroom and activated automatically to record from 8PM to 8AM. Recording will occur for 3 consecutive nights.
The cameras will record posture and later during analysis, time spent in each primary (prone, supine) and intermediate (supported sidelying and 3/4 prone) posture will be calculated. In addition, the number of posture shifts per night and the number of long periods of immobility (no posture shift for 30 minutes) will be calculated.
Intervention code [1] 289623 0
Not applicable
Comparator / control treatment
Comparisons will be made between healthy group and pain groups (cervical and lumbar)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292414 0
Video analysis determining time spend in each primary and intermediate sleep posture
Timepoint [1] 292414 0
Baseline
Primary outcome [2] 292475 0
Numerical Rating Scale - Bothersomeness
Timepoint [2] 292475 0
Baseline
Primary outcome [3] 292476 0
Numerical Rating Scale - Pain
Timepoint [3] 292476 0
Baseline
Secondary outcome [1] 308896 0
Medical Outcomes Study 36-Item Short-Form Health Survey
Timepoint [1] 308896 0
Baseline
Secondary outcome [2] 309049 0
Spine Functional Index (SFI-10)
Timepoint [2] 309049 0
Baseline
Secondary outcome [3] 309050 0
Neck Disability Index
Timepoint [3] 309050 0
Baseline
Secondary outcome [4] 309051 0
Rowland Morris Disability Questionnaire
Timepoint [4] 309051 0
Baseline
Secondary outcome [5] 309052 0
Hospital Anxiety and Depression Scale
Timepoint [5] 309052 0
Baseline
Secondary outcome [6] 309053 0
Insomnia Severity Index
Timepoint [6] 309053 0
Baseline
Secondary outcome [7] 309054 0
Pittsburgh Sleep Quality Index
Timepoint [7] 309054 0
Baseline
Secondary outcome [8] 309055 0
Numerical Rating Scale - Stiffness
Timepoint [8] 309055 0
Baseline
Secondary outcome [9] 309056 0
Numerical Rating Scale - Quality of Sleep
Timepoint [9] 309056 0
Baseline

Eligibility
Key inclusion criteria
Three groups will be recruited for this study. All persons will be required to be fluent and literate in English.

One group will be healthy volunteers with no spinal symptoms.

The second group will include volunteers who experience predominantly cervical pain or stiffness or bothersomeness, greater than or equal to 3/10 on a numerical rating scale (NRS), that is greatest lying in bed or on rising (within 30 minutes) and occurs 4 or more times per month.

The third group will include volunteers who experience predominantly lumbar pain or stiffness or bothersomeness, greater than or equal to 3/10 on a numerical rating scale (NRS), that is greatest lying in bed or on rising (within 30 minutes) and occurs 4 or more times per month.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 18 years and greater than 45 years of age, medical conditions or devices that prevent person from sleeping in all postures e.g. severe OA, esophageal reflux, breathing apparatus, late stage pregnancy, coexisting medically diagnosed inflammatory conditions or unremitting pain e.g. RA, AS, radicular pain, taking medically prescribed hypnotic or relaxant
medications and previously treated by main researcher for spinal pain.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289438 0
University
Name [1] 289438 0
Curtin University
Address [1] 289438 0
Kent Street, Bentley WA 6012
Country [1] 289438 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley WA 6012
Country
Australia
Secondary sponsor category [1] 288128 0
None
Name [1] 288128 0
Address [1] 288128 0
Country [1] 288128 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291197 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291197 0
Kent Street, Bentley WA 6012
Ethics committee country [1] 291197 0
Australia
Date submitted for ethics approval [1] 291197 0
16/06/2014
Approval date [1] 291197 0
15/07/2014
Ethics approval number [1] 291197 0

Summary
Brief summary
Some sleep postures place rotation and extension loads on spinal tissues. If maintained for prolonged periods of time, they could potentially cause pain and stiffness.
The hypothesis of this study is that prone and 3/4 prone postures will increase spine symptoms and that people sleeping in these positions will have more frequent symptoms and a poorer quality of sleep.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49314 0
Mr Doug Cary
Address 49314 0
School of Physiotherapy and Exercise Science
Curtin University, GPO Box U1987, Kent Street, Bentley WA 6845
Country 49314 0
Australia
Phone 49314 0
+618 90715055
Fax 49314 0
Email 49314 0
douglas.cary@postgrad.curtin.edu.au
Contact person for public queries
Name 49315 0
Mr Doug Cary
Address 49315 0
School of Physiotherapy and Exercise Science
Curtin University, GPO Box U1987, Kent Street, Bentley WA 6845
Country 49315 0
Australia
Phone 49315 0
+618 90715055
Fax 49315 0
Email 49315 0
douglas.cary@postgrad.curtin.edu.au
Contact person for scientific queries
Name 49316 0
Mr Doug Cary
Address 49316 0
School of Physiotherapy and Exercise Science
Curtin University, GPO Box U1987, Kent Street, Bentley WA 6845
Country 49316 0
Australia
Phone 49316 0
+618 90715055
Fax 49316 0
Email 49316 0
douglas.cary@postgrad.curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Information will be presented in peer reviewed documents
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary